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Status unknownNCT02495012Updated Jul 13, 2015

Anfibatide Treatment in STEMI Patients

A Phase 2 interventional study of placebo and Anfibatide in ST Segment Elevation Myocardial Infarction, sponsored by Lee's Pharmaceutical Limited. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-07-13.

Sponsored by Lee's Pharmaceutical Limited · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.

Read the detailed description

Anfibatide is a snake venom, and we have investigated it in humans for many years with phase 1\&2a studies. A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.

02

Conditions studied

  • ST Segment Elevation Myocardial Infarction

Keywords

  • efficacy
  • safety
  • STEMI
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 240 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Lee's Pharmaceutical Limited is the lead sponsor of 73 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18-75 years;
  2. Fulfill the standard of direct PCI: ST Segment Elevation Myocardial Infarction occurred \< 12 hours (ST Segment Elevation or New Left Bundle Branch Block (LBBB), combined myocardial ischemia chest pain medical history or the dynamic change of cardiac marker (troponin and/or CK-MB);
  3. Patients who will receive PCI and suitable for angioplasty and stent placement;
  4. Patients, or their family or guardian give signed informed consent forms.

Exclusion criteria

Exclusion Criteria:

  1. Patients with weight \< 50kg;
  2. Patients with severe hepatic or renal dysfunction, alanine aminotransferase (ALT) exceeds 3 times the normal maximum reference level, creatinine clearance level \< 30ml/min or serum creatinine ≥ 200μmol/L or ≥2.5mg/dl;
  3. Patients with severe hemodynamic instability;
  4. Patients who will receive 2 times or more PCI treatment;
  5. Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiac shock;
  6. Patients with untreated hypertension (SBP > 180mmHg or DBP > 110mmHg) or hypotension shock (SBP \< 90mmHg);
  7. Patients received GPIIb/IIIa receptor antagonists and/or thrombolytic therapy before randomization;

    1. Used eptifibatide and tirofiban in the past 12 hours before the randomization;
    2. Used abxicimab in the past 7 days before the randomization;
    3. Have received thrombolytic therapy before the randomization;
  8. Patients who need a long-term treatment of clopidogrel;
  9. Patients who have received enoxaparin sodium injection before the surgery;
  10. Patients who have hemorrhage risk:

    1. Suffered from ischemic stroke or transient ischemic attack (TIA) in the past 12 months;
    2. Suffered from hemorrhage stroke, or other life-long neuronal dysfunction;
    3. Suffered from tumor, arteriovenous malformation in brain and aneurysms;
    4. Suffered from traumatic brain injury in the past 3 months, or received major surgery;
    5. Received percutaneous coronary intervention (PCI) in the past 6 months;
    6. Have received coronary artery bypass graft therapy (CABG);
    7. Receiving long-term oral anticoagulants therapy;
    8. Suffered from active peptic ulcer, urinary and reproductive tract hemorrhage, or other active hemorrhage.
  11. Patients with coagulation disorder:

    1. Known as international normalized ratio > 2*;
    2. Patients with coagulation abnormalities or other hemorrhagic tendency (including inherited hemorrhagic diseases, e.g. Von Willebrand disease or hemophilia; acquired hemorrhagic diseases; and other clinically identified hemorrhagic diseases with unsolved rationale);
    3. Hematology test shows platelet count \< 100x109mm3/L, or hemoglobin \< 100g/L;
    4. Recorded clopidogrel-related thrombocytopenia or agranulocytosis;
  12. Life expectancy \< 1 year;
  13. Patients who have implemented with pacemaker, and contraindicated to MRI examination;
  14. Patients who are allergic constitution or allergic to any component of aspirin, clopidogrel, creatinine, antiplatelet thrombolysin and investigational product;
  15. Women in pregnant or lactation period, or women of child-bearing age do not take efficient contraception measures;
  16. Patients who are participating or will be participating in other clinical trials;
  17. Patients who have participated in clinical trials of antiplatelet thrombolysin or other related trials;
  18. Patients who are not suitable for participating in this clinical trial according to the investigator's judgment, including who are unable or unwilling to follow the protocol;
  19. Patients who participated in other clinical trials in the past 3 months.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
240 participants (estimated)

Study arms

  • Placebo comparator
    control

    5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours

    Drug: placebo

  • Active comparator
    treatment

    5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours

    Drug: Anfibatide

Interventions

  • Drugplacebo

    Freeze-dried powder without snake venom will be dissovled in saline

  • DrugAnfibatide

    Freeze-dried powder with snake venom will be dissovled in saline

06

What researchers measure

Primary outcomes

  1. ratio of TMPG grade 2 and grade 3

    After PCI, TMPG grade will be evaluated and

    Time frame: within 24 hours

Secondary outcomes

  1. inhibition rate of platelet aggregation and GP1b receptor combination rate

    Baseline, 15-20 minutes after injection, 24-26 hours after injection, 48-50 hours after injection, 8-10 hours after the cease of medication, the comment and analysis of the inhibition rate of platelet aggregation and GP1b receptor combination rate

    Time frame: 48 hours

  2. Patients ratio of no-reflow to slow-flow in coronary artery after PCI therapy

    Time frame: 24 hours

  3. Analysis of iconography reference: instant TIMI, CTFC and TMPG before/after the target vessel revascularization PCI therapy

    Time frame: 24 hours

  4. The depression level of ST segment from right after the PCI therapy to 2 hours later

    i. Complete: depression level ≥ 70% ii. Partially: 30% ≤ depression level \< 70% iii. None: \< 30%

    Time frame: within 24 hours

  5. Compare the baseline troponin level to the troponin level at 24-26 hours after injection and at 3 days after the surgery respectively

    Time frame: 72 hours

  6. (6) Check the CMR at 3-5 days after the surgery, evaluate the Myocardium Salvage Index (MSI)

    Time frame: 5 days

  7. (7) While surgery and hospitalization, follow the ratio and dose as suggested by the surgeon in case of emergency use of GP IIb/IIIa receptor antagonist or other antiplatelet drug

    Time frame: 5 days

  8. (8) Clinical endpoint 30 days after surgery (caused by death, non-fatal myocardial infarction reissue, blood clot formation after stent implantation, non-fatal stroke, target lesion revascularization reissue) and the analysis of the causes

    Time frame: 30days

  9. Recorded hemorrhage issues for 30 days after the surgery (BARC hemorrhage standard)

    Time frame: 30days

07

Study locations

1 site
  • Peking University First hospiatl
    Beijing, 100000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02495012
Lead sponsor
Lee's Pharmaceutical Limited
Responsible party
Sponsor
First posted
Jul 13, 2015
Start date
Aug 2015
Primary completion
Mar 2016 (estimated)
Completion
May 2016 (estimated)
Last update
Jul 13, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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